CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS 2800TFX23MM

GUDID 00690103194098

CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS

Edwards Lifesciences LLC

Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis

• Primary Device ID: 00690103194098
• NIH Device Record Key: 87b53d00-7fa6-432e-b728-3a860e62b6b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS
• Version Model Number: 2800TFX
• Catalog Number: 2800TFX23MM
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103194098 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P860057

FDA Product Code

• DYE: Replacement Heart-Valve

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-05
• Device Publish Date: 2019-11-27

On-Brand Devices [CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS]

• 00690103194104: CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS
• 00690103194098: CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS
• 00690103194128: CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS